Altus to initiate Ph III ALTU-135 trial in 2nd-qtr 2007

Massachusetts, USA-based Altus Pharmaceuticals, which is focused on oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders, says that it plans to initiate a Phase III clinical trial of ALTU-135 in cystic fibrosis patients with pancreatic insufficiency in the second quarter of 2007.

ALTU-135, the company's orally-administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This combination is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals.

In July of this year, Altus announced that one of three blended ALTU-135 lots showed an unexpected reduction in lipase activity. During the past three months, it initiated an investigation and conducted additional manufacturing development work to support its intended Phase III clinical trial. Work carried out during the investigation established that the observed lower potency was due to characteristics of the assay used to measure activity and not a result of a loss of enzyme activity.